Long term treatment of uterine fibroids with ulipristal acetate
Repeated 3-month courses of ulipristal acetate control bleeding and pain, reduce fibroid volume, and restore quality of life over the long term in patients with fibroids.
Jacques Donnez, M.D., Francisco Vázquez, M.D., Janusz Tomaszewski, M.D., Kazem Nouri, M.D., Philippe Bouchard, M.D., Bart Fauser, M.D., David H. Barlow, F.R.C.O.G., Santiago Palacios, M.D., Olivier Donnez, M.D., Elke Bestel, M.D., Ian Osterloh, M.R.C.P., Ernest Loumaye, M.D. for the PEARL III and PEARL III extension Study Group
Volume 101, Issue 6, Pages 1565–1573.e18
To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids.
Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo.
European clinical gynecology centers.
Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding.
Patients received up to four 3-month courses of UPA 10 mg daily, immediately followed by 10-day double-blind treatment with NETA (10 mg daily) or placebo.
Main Outcome Measure(s):
Amenorrhea, fibroid volume, endometrial histology.
After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2–6 days). Median fibroid volume change was −45% (interquartile range, −66%; −25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were −63%, −67%, and −72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology.
Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids.
Clinical trial registration:
ClinicalTrials.gov (www.clinicaltrials.gov) registration numbers NCT01156857 (PEARL III) and NCT01252069 (PEARL III extension).